Kornimate/medical-research-clean huggingface dataset:
study of sivelestat sodium hydrate in acute lung injury (ali) associated with systemic inflammatory response syndrome (sirs) in japan

Conditions: Acute Lung Injury; Systemic Inflammatory Response Syndrome

Summary: the purpose of this study is to confirm the efficacy and safety of sivelestat in patients with acute lung injury associated with systemic inflammatory response syndrome. the results will be compared to the study with conventional treatment without sivelestat.


Eligibility criteria:
inclusion criteria: 1. patients with systemic inflammatory response syndrome (sirs) 2. patients with acute lung injury (ali) assessed using the criteria specified by the american-european consensus conference 3. within 72 hours of onset of lung injury 4. other inclusion criteria as specified in the protocol exclusion criteria: 1. already administrated sivelestat before enrollment in the study 2. neuromuscular disease that impairs spontaneous ventilation 3. severe central nervous system disease 4. bone marrow transplant 5. lung transplant 6. severe chronic liver disease 7. neutropenia (neutrophil count: below 1000/mm3) 8. other exclusion criteria as specified in the protocol

Keywords: sivelestat sodium hydrate acute lung injury systemic inflammatory response syndrome elaspol acute lung injury (ali) associated with systemic inflammatory response syndrome (sirs)
phase 1/2 clinical study of lutetium lu 177 jh020002 injection in patients with advanced prostate cancer

Conditions: Prostate Cancer

Summary: the study is being conducted to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of lutetium lu 177 jh020002 injection in adult patients with advanced prostate cancer.


Eligibility criteria:
inclusion criteria: * subjects are required to get informed consent prior to the trial and sign a written informed consent form voluntarily. * male, age ≥18 years. * ecog score 0 - 2. * must have a life expectancy \>6 months. * histologically and/or cytologically confirmed adenocarcinoma of the prostate (except for those with neuroendocrine or small cell prostate cancer clinical features). * participants must have a castrate level of serum/plasma testosterone (\< 50 ng/dl, or \< 1.7nmol/l). exclusion criteria: * diagnosed with other malignancies, apart from: adequately treated skin basal cell carcinoma or superficial bladder cancers from which the patient has been disease-free for more than 3 years as confirmed by a physician. * participants with a history of central nervous system (cns) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. * previous treatment with strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223 or hemi-body irradiation \<6 months prior to date of first administration of investigational drug. * previous psma-targeted radioligand therapy. * previous radiotherapy for prostate cancer within 4 weeks prior to date of first administration of investigational drug. * any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy, poly adenosine diphosphate-ribosyl polymerase inhibitors (parpi) or biological therapy within 4 weeks prior to date of first administration of investigational drug. * must not take part in other investigational therapies within 4 weeks prior to date of first administration of investigational drug. * history of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.

Keywords: prostate cancer
connecting black families in houston, texas to hereditary cancer genetic counseling, genetic testing, and cascade testing by using a simple genetic risk screening tool and telegenetics

Conditions: Breast Cancer; Colorectal Cancer

Summary: to identify black individuals who are eligible for genetic testing through trusted community organizations, and to connect black individuals and their families to genetic testing and counseling so that they can know their cancer risk and how to decrease it.

primary objectives: * to identify 300 black families, at least one individual per family, eligible for genetic testing using our validated simple genetic risk screening tool (grst) 1, via collaboration with trusted community organizations. for individuals eligible for genetic testing, we will counsel them about genetic testing, including reviewing grst results, explaining why they are eligible for genetic testing as part of standard-of-care, explaining what this entails, offering on-site or remote genetic testing, and explaining that they will be connected to a genetic counselor if they have a pathogenic mutation (pv) of a variant of unknown significance (vus), including resources for family cascade genetic testing. * to provide genetic testing to 150 black individuals and families and provide genetic counseling and risk reduction resources to individuals with a pv or vus, including cascade genetic testing for their family members.

Eligibility criteria:
inclusion criteria: * any participant over 18 years old who self-identifies as black or african-american and signs an informed consent form, also referred to as the 'permission to contact' form, to be part of our study. exclusion criteria: none
psychological traits, sexuality and quality of life in patients with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: a prospective assessment of psychological characteristics, quality of life and sexuality in naïve patients.

this project with pcos patients include an assessment of quality of life and sexuality in naïve patients. hypothesizing that pcos women would show higher rates of psychological alterations, this study is aimed to investigate the association between polycystic ovary syndrome (pcos) and psychological disturbances, including anger and to analyze whether the biochemical/phenotypical features of pcos may play a role in the type and severity of psychological disorders.

Eligibility criteria:
inclusion criteria: pcos patients without gestational desire who met the following criteria * oligomenorrhea (cycles lasting \>35 days) or amenorrhea (no periods in 6 months) * hyperandrogenemia/hyperandrogenism hirsutism ferriman-gallwey score \> 12 obvious acne or pronounced alopecia androgen levels over normal female range exclusion criteria: * prior psychiatric diagnosis * current use of psychiatric medications * difficulties with language comprehension in case of non-nationals. * yatrogenic hirsutism, * other endocrine deseases with hyperandrogenism or that may influence the final results ovarian or adrenal neoplasia prolactinoma cushing's syndrome congenital adrenal hyperplasia diabetes mellitus thromboembolic disease * patients who had received any drug therapy for hirsutism over the last 6 months

Keywords: pcos quality of life sexuality psychological traits
botulinum toxin type a in diabetic peripheral neuropathy

Conditions: Diabetic Neuropathies

Summary: background: diabetes mellitus is commonly complicated by diabetic peripheral neuropathy. due to common side effects and poor tolerance to medication, poor adherence to medication is common in diabetic peripheral neuropathy. botulinum toxin a intradermal injection has proved efficacy in cases of diabetic peripheral neuropathy however there is a need to compare its effect with other lines of treatment. the aim of the study was to compare botulinum toxin type a verses conventional oral treatment as a second line treatment of painful diabetic peripheral neuropathy. this study was conducted as a comparative study on 30 patients with type 2 diabetes mellitus proved by nerve conduction study on carbamazepine. patients were divided randomly into 3 groups. first group was add on duloxetine, second was add on gabapentin and the third group was injected intradermal with botulinum toxin a.

this study is a comparative study on 30 patients with type 2 diabetes mellitus proved by nerve conduction study on carbamazepine. patients were divided randomly into 3 groups. first group was add on duloxetine, second was add on gabapentin and the third group was injected intradermal with botulinum toxin a. base line assessment before treatment and follow up assessment as performed the treatment options were explained to the patients and the choice of botulinum toxin a intradermal injection was the patient own decision based on inability to be tolerate or adhere to oral treatment.

Eligibility criteria:
inclusion criteria: * diabetic patients type 2 were included on single line of treatment with carbamazepine exclusion criteria: * any sever medical condition that might interfere with the results.
a study of gemcitabine plus nab-paclitaxel with or without fg-3019 in participants with locally advanced, unresectable pancreatic cancer

Conditions: Pancreatic Cancer (Unresectable)

Summary: this is a phase 1/2 trial to evaluate the safety, tolerability, and efficacy of fg-3019 administered with gemcitabine and nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.


Eligibility criteria:
key inclusion criteria: * male, or non-pregnant and, non-lactating female * histologically proven diagnosis of pancreatic ductal adenocarcinoma (pdac) * radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per national comprehensive cancer network® \[nccn®\] criteria) * laparoscopic confirmation that pdac is locally advanced. biliary stents are permitted. * measurable disease as defined by recist 1.1 * eastern cooperative oncology group (ecog) performance status 0 or 1 * adequate liver, bone marrow, and renal function * agree to use contraception per protocol * less than grade 2 pre-existing peripheral neuropathy key exclusion criteria: * prior chemotherapy or radiation for pancreatic cancer * solid tumor contact with superior mesenteric artery (sma) \>180° * previous (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer and in situ carcinomas) * major surgery, within 4 weeks prior to day 1 on study * history of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies * exposure to another investigational drug within 42 days of first dosing visit, or 5 half-lives of the study product (whichever is longer) * uncontrolled intercurrent illness * any medical condition that, in the opinion of the investigator, may pose a safety risk to a participant in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation. * current abuse of alcohol or drugs

Keywords: locally advanced pancreatic cancer unresectable pancreatic cancer
endometrial safety study of transdermal testosterone (300 mcg/day) in naturally postmenopausal women

Conditions: Hypoactive Sexual Desire Disorder

Summary: this study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.

naturally postmenopausal women with hypoactive sexual desire disorder (hsdd) will be randomized into a 52-week, multicenter, double-blind (db), parallel-group, placebo-controlled study. patients will be stratified based on whether they use concomitant estrogen/progestin therapy and then randomized in a 4:1 ration to receive either testosterone transdermal system (300 mcg/day) or placebo. patients using estrogen/progestin at the start of the study should maintain this therapy throughout the study; patients not using estrogen/progestin at the start of the study should not initiate estrogen/progestin therapy throughout the study. endometrial biopsies and transvaginal ultrasounds will be collected/performed at screening and study exit for all patients. safety will be assessed by adverse events, reports of vaginal bleeding, lipids, serum chemistry, and hematology. physical exams, pap smears, and mammograms will be monitored.

Eligibility criteria:
inclusion criteria: * women will be screened for study participation and must be at least one year post menopausal, 45-70 years old, in general good health, and may or may not be on hormone therapy, and must have low sexual desire which causes distress. exclusion criteria: * women will be screened for study participation and must not be using androgen therapy or have any medical, physical, psychological, or pharmacological condition that could make participation unsafe or confound the safety evaluation.

Keywords: natural menopause
effect of sunflower lecithin supplementation on meibomian gland function in adults with dry eye disease

Conditions: Dry Eye Disease; Meibomian Gland Dysfunction

Summary: this prospective study will evaluate the effect of oral sunflower lecithin dietary supplementation on meibomian gland function in adults with dry eye disease.

enrolled patients in the active arm of the study (n=20) will receive a daily dose of four sunflower lecithin 1,200 mg soft-gel capsules for a duration of 90 days. patients in the control arm (n=10) will receive four doses of a 1,000 mg placebo soft-gel capsules (containing olive oil). patients will be evaluated for meibomian gland function and signs and symptoms of dry eye at baseline and at the end of the study using a standardized eye dryness survey (speed survey), tear breakup time measurement, meibomian gland score, and a rapid in-office assessment of years (inflammadry).

Eligibility criteria:
inclusion criteria: * age greater than18 at the time of informed consent * clinical diagnosis of dry eye in both eyes * fluorescein tear film break-up time (tbut) less than 10s in both eyes * the presence of lid margin scaling, telangiectasia, collarette or meibomian gland plugging on slit-lamp examination * best-corrected visual acuity (bcva, snellen) of 20/40 or better in each eye * patient evaluation of eye dryness (speed) questionnaire score \>6 to \<14 * must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions exclusion criteria: * any pre-existing ocular disease other than dry eye disease * patients with inability to swallow soft gel capsules * severe illness, pregnancy or breastfeeding, smoking, and regular use of strongly anticholinergic drugs. * drastic change of food and/or food supplements within the last month. * other food supplement with fatty acids * evidence of acute ocular infection and⁄or intraocular inflammation within 1 month prior to the onset of this study. * ocular surgery within the last 6 months. * patients treated with topical ocular, steroidal or non-steroidal, anti-inflammatory treatment within the last month. * occlusion therapy with lacrimal or punctum plugs within the last 3 months. * alterations of the lacrimal drainage system * eyelid abnormalities * patients on oral tetracycline or corticosteroids * active allergy or infection at the ocular surface
study of oxaliplatin/5-fu/leucovorin plus vatalanib versus oxaliplatin/5-fu/leucovorin in patients with metastatic colorectal cancer.

Conditions: Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Summary: to compare treatment with oxaliplatin/5-fu/leucovorin plus vatalanib versus oxaliplatin/5-fu/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and are seeking first chemotherapy treatment


Eligibility criteria:
inclusion criteria: * patients with metastatic colorectal cancer coming for initial chemotherapy * documented metastatic colorectal cancer * who performance status of 0, 1, or 2 * measurable tumors * adequate hematologic status, liver and kidney function * life expectancy greater than 12 weeks * written informed consent obtained exclusion criteria: * history or presence of central nervous system disease * patients with a history of another primary cancer within 5 years * prior chemotherapy for metastatic colorectal cancer * prior full field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks before entry to study * major surgery within 4 weeks or minor surgery within 2 weeks before entry to study * investigational drugs within 4 weeks before entry to study * prior therapy with anti-vegf agents * any prior therapy with oxaliplatin or allergy to platinum-containing drugs * peripheral neuropathy with functional impairment * female patients who are pregnant or breast feeding * any severe or uncontrolled medical conditions which could prevent participation in study * patients who are taking coumadin other protocol-defined inclusion / exclusion criteria may apply

Keywords: colorectal cancer ptk787 vatalanib vegf inhibitor oxaliplatin angiogenesis rectal cancer colon cancer colorectal carcinoma colorectal tumor
registry of catheter intervention in pulmonary embolism

Conditions: Pulmonary Embolism; Pulmonary Embolism Acute Massive; Pulmonary Embolism Acute; Pulmonary Embolism and Thrombosis; Pulmonary Thromboembolisms

Summary: multicenter longitudinal observational ambispective (retrospective cases from 2014 and prospective from 2018 onwards) cohort study. the registry recruits a series of consecutive patients admitted for moderate-high risk or high-risk pulmonary embolism (according to 2019 european society of cardiology guidelines) treated invasively. this study aims to describe the acute management of the safety and effectiveness of different percutaneous interventions for acute pulmonary embolism.


Eligibility criteria:
inclusion criteria: * adult patients (aged 18 years old or older) * confirmed diagnosis of acute pe (on computed tomography or echocardiogram plus pulmonary angiography) * high-risk pe or intermediate-high risk according to esc risk stratification in the 2019 guidelines (briefly, elevated cardiac biomarkers \[troponin or n-terminal pro-b-type natriuretic peptide\], and right ventricle to left ventricle ratio \> 0.9 \[on computed tomography or echocardiogram\], and pe severity index iii to iv or simplified pe severity index=1 * eligibility for catheter-directed intervention exclusion criteria: * unconfirmed diagnosis of pe * undefined risk stratification, and * pe with uncertain chronology or beyond seven days of symptom initiation.

Keywords: aspiration thrombectomy percutaneous aspiration thrombectomy local thrombolysis
tizanidine and superficial cervical block on pain after thyroidectomy

Conditions: Thyroidectomy

Summary: thyroid surgery is a quite painful procedure performed in a sensitive skin area of the human body. unless pain is treated adequately thyroid surgery may cause severe postoperative pain and discomfort for the patients. a2-agonists are sympatholytic and centrally acting antihypertensive agents. in addition to their hypotensive effect, a2-agonists are also used in anesthetic practice for their sedative and analgesic effects. tizanidine is a centrally acting a2-agonist with muscle relaxant, sedative and anxiolytic properties. this drug is widely used for the treatment of spasticity and has recently been used to treat musculoskeletal pain conditions. ultrasound (us) guidance during regional anesthesia practices has been a revolutionary advancement to improve success and safety of regional anesthesia. analgesic effect of us guidance superficial cervical plexus block (scpb) in patients undergoing thyroid surgery has not been reported yet. the aim of this study was to evaluate the analgesic effect of preemptive oral single dose tizanidine and us guidance scpb in patients undergoing elective thyroid surgery. the investigators hypothesis that: tizanidine and us guided scpb can reduce the pain scores, analgesic consumption, analgesic related side effects.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist's physiologic state i-iii patients undergoing thyroidectomy exclusion criteria: * chronic pain * bleeding disorders * renal or hepatic insufficiency * patients on chronic non-steroidal anti-inflammatory medications * recurrent goiter * emergency cases

Keywords: thyroidectomy pain tizanidine postoperative analgesia ultrasound guided superficial cervical plexus block
kinesio tape application with edf technique on active trigger points of upper trapezius muscle

Conditions: Myofascial Pain Syndrome; Myofascial Trigger Point Pain

Summary: in this double-blinded, prospective randomized sham controlled multi centered study, the aim was to investigate the efficacy of edf technique on pain intensity, number of active trps, cervical rom and disability levels in patients with mps on upper trapezius (ut) muscle.180 patients were randomly allocated to kinesio taping (kt) group or sham group. applications were done two times 1 week apart. vas-pain scores, disability scores , cervical rom angles and number of trigger points were evaluated as outcome parameters. vas-pain scores and number of trigger points were assessed at baseline, after 1 week and after 2 weeks (at the end of the study). cervical rom angles and disability (measured by neck pain disability scale) were assessed at baseline and at the end of the study. both groups received home exercise program. as a result application of kt with edf technique to the ut muscle provided a significant improvement in pain level, disability, number of active trps and cervical rom angles and found superior to sham application.

in order to determine the sample size, power analysis was performed using the g\*power version 3.1.9.2 program. effect size of 1.26 was set up for the vas pain score changes between groups as per the previous study. for power calculations, a confidence level (α) of 0.05 and a power level of 0.95 was assumed. fifteen patients per group in each center was required. 15 patients were randomized to two groups in each center by numbered envelopes method. the group 1 and group 2 notes were put into to the closed envelopes separately, and each patient randomly chose an envelope and gave it to a physician who was not the researcher. one researcher evaluated the patient and then collected the data, and the second researcher who was certified as kt practitioner applied the kt. both patients and the researcher who recorded the data were blinded to treatment allocation.

Eligibility criteria:
the inclusion criteria: * presence of an at least one active trp and palpable taut band in the ut muscle * pain duration less than 3 months * pain visual analog score vas≥4 * being between 18 and 50 years of age the exclusion criteria: * diagnosis of neuromuscular, rheumatic, inflammatory diseases * malignancy * uncontrollled systemic conditions * infections * trauma * neck surgery * pregnancy * obesity (bmi≥ 30 kg/m2).
an observational study of neorecormon (epoetin beta) in anemic patients with non-myeloid malignancy

Conditions: Anemia

Summary: this observational, prospective, multicenter study will evaluate the treatment response rate and the safety of neorecormon (epoetin beta) in anemic patients with non-myeloid malignancy. in addition to neorecormon, patients receive chemotherapy for their malignancy. data will be collected for 16 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * presence of solid-tumor or non-myeloid malignancy * patients receiving chemotherapy * eastern cooperative oncology group (ecog) performance status 0-2 * patients require neorecormon exclusion criteria: * hypersensitivity to the drug * uncontrolled hypertension * female patients if pregnant and/or lactating
omentectomy in radical gastrectomy for gastric cancer trial

Conditions: Omentum; Stomach Neoplasms

Summary: in patients with gastric cancer, traditionally a complete omentectomy is performed as part of a radical gastrectomy with a modified d2 lymph node dissection. the omentectomy increases operation time significantly, especially in laparoscopic procedures. patients remain more vulnerable for peritoneal infections and intestinal adhesions following omentectomy. furthermore one can debate whether a complete omentectomy is indicated from an oncologic viewpoint. in the present study we prospectively evaluated the presence of tumor load in the greater omentum of patients with potentially curative gastric cancer.


Eligibility criteria:
inclusion criteria: * an in potentially curative gastric cancer * age \> 18 year exclusion criteria: * palliative resection * age \< 18 year